NCT00198458已完成1 期
Clinical Evaluation of Hypersensitivity Reaction to Vitrase (Ovine Hyaluronidase, 150 USP Units/mL) Open Label, Normal Volunteer Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Hypersensitivity
研究概览
简要总结
The objective of this study was to rule out a greater than 10% incidence of hypersensitivity to Vitrase following a single intradermal injection of 3 USP units Vitrase. Less than or equal to a 10% hypersensitivity response was considered acceptable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreed to avoid disallowed meds
排除标准
- •Known hypersensitivity to hyaluronidase and/or bee sting
- •Previous known exposure to ovine hyaluronidase or bovine hyaluronidase
- •Atopic individuals assessed by medical history
- •Topical/inhaled/systemic corticosteroids within 30 days
- •Concurrent use of antihistamines or anti-inflammatory during study
- •Active or chronic disease likely to affect immune function
- •History of alcohol/drug abuse within 6 months
研究组 & 干预措施
Vitrase
Experimental
A single intradermal dose of 4.5 USP units of Vitrase at one site and the same volume of saline at a distant site for comparative control.
干预措施: Vitrase (Drug)
结局指标
主要结局
Hypersensitivity
时间窗: 1-2 days
Incidence of hypersensitivity to Vitrase following a single intradermal injection of 4.5 USP units Vitrase.
次要结局
未报告次要终点
研究者
研究点 (1)
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